Welcome to UpcomingEvents.com!! We hope to see you at an event SOON!
Search

Select Region

Featured Regions

Philadelphia, PA Baltimore, MD Atlantic City, NJ

Not what you're looking for? See All Cities

Or

Search by Zip

Compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR


This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.
It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation.
The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
Understand the specific requirements associated with local and SaaS/cloud hosting solutions.
It details the requirements for HIPAA Protect Health Information (PHI)

Course Objectives:
Reduce costs, usually by two-thirds, for compliance with electronic records
Learn how to use electronic records and electronic signatures to maximize productivity
Understand what is expected in Part 11 and Annex 11 inspections so you are prepared
Avoid 483 and Warning Letters
Understand the responsibilities and specific duties of your staff including IT and QA
Understand your responsibilities and liabilities when using SaaS/cloud
Learn how HIPAA expands Part 11 compliance

Read More

View Less

Top